TEVA-DAPAGLIFLOZIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAPAGLIFLOZIN

Available from:

TEVA CANADA LIMITED

ATC code:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

DAPAGLIFLOZIN 5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0156370001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-05-15

Summary of Product characteristics

_Teva-Dapagliflozin Page 1 of 72_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-DAPAGLIFLOZIN
dapagliflozin tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario M1B 2K9
Canada
Date of Initial Authorization:
DEC 21, 2021
Submission Control No: 246884
_Teva-Dapagliflozin Page 2 of 72_
RECENT MAJOR LABEL CHANGES
NOT APPLICABLE.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.5
Missed Dose
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